103832 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10325 Disclosure and 

Recordkeeping Requirements for 

Grandfathered Health Plans Under the 

Affordable Care Act 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collections 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Disclosure and 

Recordkeeping Requirements for 

Grandfathered Health Plans under the 

Affordable Care Act; Use: Section 1251 

of the Affordable Care Act provides that 

certain plans and health insurance 

coverage in existence as of March 23, 

2010, known as grandfathered health 

plans, are not required to comply with 

certain statutory provisions in the Act. 

The final regulations titled ‘‘Final Rules 

under the Affordable Care Act for 

Grandfathered Plans, Preexisting 

Condition Exclusions, Lifetime and 

Annual Limits, Rescissions, Dependent 

Coverage, Appeals, and Patient 

Protections’’ (80 FR 72192, November 

18, 2015) require that, to maintain its 

status as a grandfathered health plan, a 

plan must maintain records 

documenting the terms of the plan in 

effect on March 23, 2010, and any other 

documents that are necessary to verify, 

explain, or clarify status as a 

grandfathered health plan. The plan 

must make such records available for 

examination upon request by 

participants, beneficiaries, individual 

policy subscribers, or a State or Federal 

agency official. A grandfathered health 

plan is also required to include a 

statement in any summary of benefits 

under the plan or health insurance 

coverage that the plan or coverage 

believes it is a grandfathered health plan 

within the meaning of section 1251 of 

the Affordable Care Act and provide 

contact information for questions and 

complaints. In addition, a grandfathered 

group health plan that is changing 

health insurance issuers is required to 

provide the succeeding health insurance 

issuer (and the succeeding health 

insurance issuer must require) 

documentation of plan terms (including 

benefits, cost sharing, employer 

contributions, and annual limits) under 

the prior health insurance coverage 

sufficient to make a determination 

whether the standards of paragraph 

§ 147.140(g)(1) of the 2015 final 

regulations are exceeded. It is also 

required that, for an insured group 

health plan (or a multiemployer plan) 

that is a grandfathered plan, the relevant 

policies, certificates, contracts of 

insurance, or plan documents must 

disclose in a prominent and effective 

manner that employers, employee 

organizations, or plan sponsors, as 

applicable, are required to notify the 

issuer (or multiemployer plan) if the 

contribution rate changes at any point 

during the plan year. Form Number: 

CMS–10325 (OMB Control Number: 

0938–1093); Frequency: On Occasion; 

Affected Public: Private Sector, State, 

Local or Tribal governments; Number of 

Respondents: 14,603; Total Annual 

Responses: 2,094,506; Total Annual 

Hours: 40. (For policy questions 

regarding this collection contact Adam 

Pellillo at 667–290–9621.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–30202 Filed 12–18–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5338] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Interstate Shellfish 

Dealer’s Certificate and Participation in 

the National Shellfish Sanitation 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of the Interstate 

Shellfish Dealer’s Certificate as well as 

the collection of other records related to 

participation in the National Shellfish 

Sanitation Program (NSSP). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 18, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 18, 2025. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 


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Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103833 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–5338 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Interstate 

Shellfish Dealer’s Certificate and 

Participation in the National Shellfish 

Sanitation Program.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Interstate Shellfish Dealer’s Certificate 

and Participation in the National 

Shellfish Sanitary Program 

OMB Control Number 0910–0021— 

Revision 

Under section 243 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

243), FDA is required to cooperate with 

and aid State and local authorities in the 

enforcement of their health regulations 

and is authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the U.S. bivalve molluscan 

shellfish industry in the NSSP. 

Molluscan shellfish consumed fresh 

(raw) and fresh frozen poses unique 

public health concerns. The safety of 

molluscan shellfish directly reflects the 

cleanliness of the waters where they are 

grown. Molluscan shellfish are sessile, 

filter-feeding organisms that pump large 

quantities of water through their bodies 

during their normal feeding process. 

The relationship between shellfish 

harvesting waters that are contaminated 

with sewage and other forms of 

pollution and food safety concerns has 

been demonstrated often. Additionally, 

bivalve molluscan shellfish must be 

held, packed, and shipped under 

sanitary conditions to prevent 

contamination subsequent to harvest 

and prior to delivery to the consumer. 

The NSSP is a voluntary cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish dealers. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

production and issues certificates for 

those dealers that meet the State or 

foreign shellfish control authority’s 

criteria. Each participating State and 

nation provides a certificate of its 

certified shellfish dealers to FDA on 

Form FDA 3038, ‘‘Interstate Shellfish 

Dealer’s Certificate’’ (available for 

download at https://www.fda.gov/ 

media/72094/download). FDA uses this 

information to publish the ‘‘Interstate 

Certified Shellfish Shippers List 

(ICSSL),’’ a monthly comprehensive 


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103834 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

listing of all molluscan shellfish dealers 

certified under the cooperative program 

(available at https://www.fda.gov/food/ 

federalstate-food-programs/interstatecertified-shellfish-shippers-list). We also 

provide information on our website at 

https://www.fda.gov/federal-state-localtribal-and-territorial-officials/statecooperative-programs/fda-nationalshellfish-sanitation-program, which 

may serve as a helpful resource to 

respondents. 

Under the authority of section 243 of 

the PHS Act, we are revising this 

information collection to also collect 

from State regulatory agencies samples 

of shellfish, along with metadata (date 

collected, temperature, and location). If 

available, we are also collecting 

analytical results needed to classify 

growing area waters for existing and 

emerging food safety hazards and to 

ensure that shellfish products of dealers 

listed on the ICSSL are safe. 

Respondents will have already 

independently collected samples at a 

given location/time (our request is for 

an additional sample to be collected and 

sent to FDA for analysis) and, in some 

cases (for requested existing analytical 

results), conducted tests associated with 

information submitted as part of 

samples and analytical results. 

Regarding the collection of samples, 

FDA will provide shipping materials for 

transport and will bear any shipping 

costs. 

The information collection also 

includes respondents providing to FDA 

documents demonstrating compliance 

with the NSSP. When a competent 

authority in another country conducts 

an evaluation to determine whether the 

U.S. food safety control measures for 

bivalve molluscan shellfish are 

equivalent to its own system of controls, 

the competent authority may require 

FDA to provide information and records 

demonstrating compliance with the 

provisions of the NSSP. Only those 

firms that comply with the NSSP would 

be permitted to export bivalve 

molluscan shellfish to a country whose 

competent authority determined that the 

U.S. system of controls is equivalent to 

their own controls. FDA uses the 

information collection to support the 

export of U.S. shellfish to countries 

whose competent authorities have 

determined the U.S. system of food 

safety controls to be equivalent to their 

own system of controls by 

demonstrating that the exporter follows 

the U.S. system of controls specified in 

the NSSP. 

For example, to implement the 

European Commission’s (EC) 

determination that the U.S. system of 

food safety controls for raw bivalve 

molluscan shellfish is equivalent to the 

European Union’s (EU) system of 

controls, the EC requires FDA to provide 

documentation collected from NSSPparticipating shellfish control 

authorities for firms seeking to export 

raw molluscan shellfish to the EU. This 

documentation includes, but is not 

limited to: 

• a list of growing areas with an 

approved classification; 

• the most recent sanitary survey for 

each growing area with an approved 

classification; and 

• the most recent inspection report 

for each dealer seeking to export bivalve 

molluscan shellfish to the EU. 

The examples above are illustrative. 

Some competent authorities may require 

additional information to conduct an 

equivalence assessment or to implement 

an equivalence determination, or both. 

We provide respondents with 

information about the specific 

documentation that is required for each 

equivalence assessment. For those 

competent authorities that recognize the 

U.S. system as equivalent, additional 

documentation may be needed to 

implement that determination. 

Form FDA 3038 may be submitted on 

paper or submitted electronically by 

State or international officials. These 

officials securely log into a shellfish 

shippers account to fill out Form FDA 

3038 electronically. The information 

obtained from the form has been 

entirely automated. The forms 

transmitted by the States, after approval 

by an FDA official, are entered into an 

FDA computer database program that 

allows the addition, deletion, download, 

and generation of the Interstate Certified 

Shellfish Shippers List, published 

monthly in PDF format, and may be 

updated daily when new data is 

available. 

Description of Respondents: 

Respondents to this collection are 

participating State regulatory agencies 

and foreign nations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA form 

No. 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total 

hours 

Submission of Interstate Shellfish Dealer’s 

Certificate.

3038 40 57 2,280 0.10 (6 minutes) ..... 228 

Submission of NSSP Compliance Documentation.N/A 13 1 13 0.25 (15 minutes) .. 3 

Submission of Samples and Analytical Results.N/A 35 2 70 0.50 (30 minutes) ... 35 

Total .......................................................... ................ ........................ ........................ ........................ ................................ 266 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


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Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103835 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

burden estimate by 35 hours and 70 

responses due to the program change of 

collecting samples and analytical 

results. We attribute the burden change 

to an increase in responses. This 

estimate is based on our experience 

with this information collection and the 

number of certificates received in the 

past 3 years. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30228 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5234] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Labeling: 

Notification Procedures for Statements 

on Dietary Supplements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of the regulation 

requiring the manufacturer, packer, or 

distributor of a dietary supplement to 

notify us that it is marketing a dietary 

supplement product that bears on its 

label or in its labeling a statement 

provided for in the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 18, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 18, 2025. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–5234 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Labeling: Notification Procedures for 

Statements on Dietary Supplements.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 


lotter on DSK11XQN23PROD with NOTICES1